Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing

Postoperative Clinical Trial

— GASTROSUTURE  

Official title:

Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01139424
• Other study ID #: 1-Fritscher-Ravens
• Secondary ID: UKSH1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 28, 2010
• Last updated: June 7, 2010
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2010
• Source: University of Schleswig-Holstein
• Contact: Annette Fritscher-Ravens, MD
• Phone: 0049-431-597-2133
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection

Exclusion Criteria:

• tubular ischemia of the upper GI tract

• inability to provide informed consent

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomosis, Surgical
• Anastomotic Leak
• Postoperative

Intervention

Device:
• endoscopic suturing
endoscopic suturing of the anastomotic leak

Locations

Country	Name	City	State
Germany	UKSH	Kiel	SH

Sponsors (2)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Ethicon Endo-Surgery

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Endpoint to be recorded during hospital stay: Composite serious adverse event endpoint for 30 days after the diagnosis of anastomotic leakage including: Death; Injury to vessels through the suture device, leading to bleeding or thrombosis; Cardiac tamponade, arrhythmia; Pneumothorax; Bleeding requiring transfusion; possible medium-term complications such as new mediastinal abscess	2 years	Yes
Primary	Technical feasibility	Technical success of the anastomotic closure	2 years	No
Secondary	Time to healing of the anastomotic leak	Scored during the hospital stay until 6 months after the original operation. Patients who die or undergo complete resection of the organ (e. g. esophagectomy with cervical fistula) are scored as "nevel healed" - i.e. censored events. Efficacy statistics need to use local historic controls and literature data. Statistical analysis will be performed using the LogRank test.	2 years	No
Secondary	Long term safety	Long term safety; Anastomotic stenosis, as assessed by endoscopy; Clinically apparent functional problems (e.g. dysphagia, incontinence)	6 months after diagnosis of anastomotic leakage	Yes